Experience

Securecell AG

• Switzerland
• Biotechnology Research
• 1 - 100 Employee

• Head of Quality & Regulatory Affairs

  • May 2018 - Present



Cendres+Métaux SA

• Switzerland
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Manager

  • Sep 2014 - Apr 2018

  Dental products (company products) and contract manufacturing (medical devices). - Management of Validation Master Plan for all company processes and equipment - Coordination and support for all validation and qualification activities (e.g. cleaning, packaging, injection molding, surface treatment, test equipment, etc.)- Planning and coordination of biological tests for process validation- Biological evaluation and testing for development projects and product validation - Risk analysis and process FMEA- Writing: reports, rationale, summaries, declarations of conformity- Support for audits (notified body, authorities, suppliers, customers)- Support for product registration (contact with our international partners regarding material biocompatibility, analytics, biological testing, infection control)- Postmarket Surveillance- Management system: implementation and optimization- Training



Gerresheimer Advanced Technologies

• Switzerland
• Medical Devices
• 1 - 100 Employee

• Project Leader

  • Aug 2012 - Aug 2014

  Development of drug delivery systems and diagnostic devices based on an innovative micro pump technology for pharmaceutical and biotechnology industries (combination products). First project: Management of an interdisciplinary project focused on the development of a medical pump variant, in collaboration with pharmaceutical partners, adapted to the delivery of special drugs (Monoclonal Antibodies, MABs) with high reactivity and reduced stability.Second project: Management of a development project for continuous glucose monitoring of patients in intensive care units. - Project planning (preparation, control, reporting and administration)- Management of operational aspects- Coordination of suppliers and internal staff- Communication and review with customers- Work with cross functional and interdisciplinary teams (mechanic, electronic, software, design, finance, product management, industrialization, quality and regulatory affairs, etc.)- Review and assessment of activities, objectives and deliverables - Evaluation of concept feasibility and implementation- Project documentation according to quality standards (ISO 13485, DHF/DMR/DHR, design control, etc.)In parallel and for different projects: support for manufacturing process, material selection and testing.



Adoptics AG

• Switzerland
• Medical Equipment Manufacturing

• R&D and Manufacturing Engineer

  • Jul 2011 - Aug 2012

  Responsible "Process development and optimization"Development of a novel accommodating intraocular lens (AIOL) to treat cataract and presbyopia (ophthalmic implants)- From feasibility to clinical study of a class III medical device- Process development, optimization and transfer- Manufacturing of implants in clean room environment for clinical study- Good manufacturing practices- Mechanical testing and optical measurements- Contact with suppliers- ISO 13485- Equipment qualification (IQ, OQ, PQ)



EPFL (École polytechnique fédérale de Lausanne)

• Switzerland
• Higher Education
• 700 & Above Employee

• Scientific Assistant

  • Jun 2010 - Jul 2011

  Research and Manufacturing Project Engineer, Bio-MEMS. Multidisciplinary project in the Laboratory of Microsystems (microsystem development and manufacturing, clean room microfabrication at Center of MicroNanoTechnology CMi) and the Laboratory of Biomechanical Orthopedics (biological experiments realization)Development and manufacturing of a microactuator for mechanical assays on cells (Bio-MEMS) – research funded by SNF to investigate the effect of mechanotransduction on Mesenchymal Stem Cells (MSC) differentiation through the use of microtechologies, cell therapy and tissue engineering as clinical prospects, protein (fibronectin) deposition methods and biological experiments on fibroblasts- Planning and coordination of technical and biological aspects- Supervision of students and trainees- Development of a silicon microsystem- Optimization of a complex process flow (SOI technology)- Clean room microfabrication of functional systems- Development of a technical method for performing cell culture on the microactuator- Protein functionalization and biological experiments on fibroblasts in P2 laboratories- Characterization and testing- Fluorescence microscopy (cells and proteins)



Johnson & Johnson

• United States
• Hospitals and Health Care
• 700 & Above Employee

• R&D Engineer, Codman Neurosciences

  • Sep 2008 - Jun 2009

  Master Thesis: "Packaging of a flow sensor and a pressure sensor for long term implants"Development of a biocompatible and hermetic encapsulation for implantable medical devices to guarantee a long shelf-life in the human body, thermal flow sensor used for the treatment of hydrocephalus Master Thesis: "Packaging of a flow sensor and a pressure sensor for long term implants"Development of a biocompatible and hermetic encapsulation for implantable medical devices to guarantee a long shelf-life in the human body, thermal flow sensor used for the treatment of hydrocephalus



HE-Arc - Haute École Arc

• Switzerland
• Higher Education
• 200 - 300 Employee

• R&D Engineer

  • Apr 2007 - May 2009

  Institute of Applied Microtechnologies (IMA)Projects in the fields of biomedical, microsystems (MEMS) and surface technologiesHydrocephalus: Development and prototyping of an implantable flow sensor – in order to allow a better management of hydrocephalus shunted patients, manufacturing and assembly methods (KTI project)Shock pump: Development and prototyping of a pump for microfluidic applications – use of SOLID technology (solid on liquid deposition)Multipol: Research (European project) to develop new approaches for SOLID technology (organic electronic applications)Multilayer coatings: Thin nanostructured films for tribological applications and operating at variable temperaturesMicro-structuration: Laser ablation of thin films for decorative applications (watch industry, accessories)